tbuckley/cabot-search huggingface dataset:
Association between palliative care consultation, hospital length of stay, and in-hospital costs in women with metastatic breast cancer in United States.
Authors: Divya S. Subramaniam, Noor Al-Hammadi, Alexandria Jenkins, Leslie J. Hinyard
Journal: Journal of Clinical Oncology (2022)

e24068 Background: Regardless of detailed advantages of palliative care for cancer patients, there is limited research about the utilization of palliative care services for women with metastatic breast cancer, particularly at the end-of-life. The purpose of this study was to determine the incidence of inpatient palliative care consultations (PCC) in women with metastatic breast cancer and to examine the association between palliative care consultation and hospital length of stay (LOS) and in-hospital costs in a nationally representative sample. Methods: Women, 18 years and older, with a metastatic breast cancer related hospitalization in the Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Database (NIS) 1998-2017 were included in the study. Multivariable logistic and linear regression analyses were used to examine the effects of patient and hospital characteristics on the receipt inpatient palliative care, length of stay and total hospital charges. SAS software survey procedures (version 9.4, SAS Institute Inc, Cary, NC) were used for all analyses to account for the sampling design of NIS. Results: Older women were associated with higher odds of getting PCC [aOR, 95% CI (60-69 yrs: 1.08 (1.01, 1.16); ≥70 yrs: 1.25 (1.17, 1.34))]. Women of races other than White [Blacks: 1.12 (1.07, 1.16); Other races 1.08 (1.04, 1.13)], and patients from Zip codes of with lower household income levels were more likely to receive a palliative care consult [0-25 th percentile: 1.17 (1.12, 1.21); 26-50 th percentile 1.05 (1.01, 1.09); 51-75 th percentile 1.06 (1.02, 1.20)]. Women receiving governmental insurance had slightly lower odds of receiving palliative care compared to women receiving commercial types of insurance [0.94 (0.91, 0.98)]. Small and medium-sized hospitals were less likely to offer the service to admitted women [0.87 (0.84, 0.91)]. Hospitals located in the Northeast, Midwest, South were associated with lower odds of offering inpatient PCC when compared to hospitals in the West. A woman with any comorbidity had higher odds of receiving a PCC during their hospital admission. Hospitals were likely to charge patients receiving palliative care services less compared to patients who did not have a PCC encounter (Estimate: -5450; 95% CI: -5968, -4936) despite being associated with higher odds of a longer hospital stay (&gt; 4 days) [1.17 (1.14, 1.20)]. Conclusions: Our study found that inpatient PCC for women with metastatic breast cancer increased LOS and hospital costs. We also found that inpatient palliative care consultation was provided to sicker patients; patients who would likely have longer length of stay, and in return, higher hospital costs compared to those without multiple acute comorbidities. Hence, targeted interventions must be implemented to increase PCC for metastatic breast cancer patients in the United States.
Cancer health disparities in the state of Georgia: African American oncology care.
Authors: Nabin Raj Karki, Kristina Zarkua, Kulsum Bano, Michael Chahin, Amany R. Keruakous
Journal: Journal of Clinical Oncology (2022)

1546 Background: Approximately 58,970 new cancer diagnoses are projected for 2022 in Georgia (GA), contributing to 18,750 deaths. African Americans (AA) make up about one-third of Georgia’s population compared to 14% of the national population. Cancer survival rates are lower for AA than non-AA for almost all cancer types. Biological factors do not account for all these differences. We explore the impact of racial disparities on cancer care in Georgia. Methods: We used 2020 behavioral risk factor surveillance system (BRFSS) data to capture patient-reported data on various demographic and health coverage variables. Oncology patients in the stage of Georgia were selected for our analysis. We evaluated the effect of racial disparities on clinical services received. Results: In the state of GA, 9,090 participants responded to the 2020-BRFSS, of which 400 partcipants had a history of cancer diagnosis other than skin cancer. Males and females comprised 37% and 63%, respectively. AA represented 15.8% of the respondents. The majority of the oncology respondents reported having health care coverage (96%) and having insurance coverage for all cancer treatments (96.8%) despite having 81.9% of the participants unemployed. Compared to non-AA, AA participants reported lower rates of health insurance payment for cancer treatment (84% v 99.3%, P = 0.0022) and lower levels of annual incomes (percentage of annual income &lt;50,000$/year was 72.3% vs 51.5%, P = 0.0151). AA participants were four times less likely to have full coverage for cancer-related treatment than non-AA (odds ratio=4.31). There was no statistically significant difference in secondary education rates, health care coverage, the inability to see a physician due to cost, receipt of summary of treatment or written instructions, denial of insurance coverage due to cancer, and clinical trial participation. Participants with at least secondary education were more likely to have full insurance coverage for all cancer treatment expenses (P = 0.0206). Conclusions: Among cancer patients in Georgia, income rates were lower in AA than in non-AA. They were also less likely to have full coverage for cancer-related treatment. Analysis suggests secondary education increases the likelihood of having full insurance coverage. Education and income disparity may have a bearing on the accessibility and quality of cancer care. Addressing these inequities on a societal level will be key in ensuring high-quality oncology care for all. [Table: see text]
Cost-effectiveness of CD19 chimeric antigen receptor T-cell (CAR-T) therapy versus autologous stem cell transplantation (ASCT) for high-risk diffuse large B-cell lymphoma (DLBCL) in first relapse.
Authors: Amar Harry Kelkar, Edward Robert Scheffer Cliff, Caron Alyce Jacobson, Gregory A. Abel, Robert Redd, Stijntje Dijk, Eline Krijkamp, M. G. Myriam Hunink, Corey S. Cutler
Journal: Journal of Clinical Oncology (2022)

7537 Background: The recently reported ZUMA-7 and TRANSFORM trials demonstrate superior event-free survival among patients with primary refractory or early relapsed DLBCL compared to salvage chemotherapy with ASCT. However, given a cost of &gt;$370,000, it is not known whether second-line CAR-T is cost-effective compared to ASCT. Thus, we developed a state-transition microsimulation model to simulate clinical outcomes and costs associated with therapy for DLBCL patients in first relapse, using ZUMA-7 and TRANSFORM data. Methods: The model begins at initiation of second-line therapy comparing salvage chemotherapy with ASCT or CAR-T therapy. We examined a three-year time horizon, including crossover to the alternative strategy therapy in the third line, as well as subsequent lines of therapy, using open-source Amua 0.3.0 software. Base case analysis was performed using 1000 first-order Monte Carlo simulations and probabilistic sensitivity analysis (PSA) was performed with 1000 simulations to test model uncertainty. Conditional probabilities of survival and disease progression were extracted from Kaplan-Meier curves from pivotal clinical trials using the WebPlotDigitizer tool. Costs were estimated from public sources in US Dollars ($) and effects were estimated in quality-adjusted life years (QALY) using published utility values. Results: Median overall survival was 15 months (95% confidence interval [CI] 13-19 months) with ASCT and 21 months (95% CI 17-29 months) with CAR-T. The PSA demonstrated costs and effectiveness per patient of $243,581 and 1.06 QALYs with ASCT and $470,150 and 1.22 QALYs with CAR-T with an incremental cost-effectiveness ratio (ICER) of $1,383,320/QALY. Incremental net monetary benefit of CAR-T versus ASCT, based on a willingness-to-pay (WTP) threshold of $200,000/QALY, was -$193,812. The break-even price for CAR-T and all subsequent therapies, based on a one-way sensitivity analysis, was $170,489. Conclusions: The model demonstrated improved survival and QALYs for the second-line CAR-T therapy, but was not cost-effective, as the ICER exceeded $1,000,000/QALY, which is higher than most accepted WTP thresholds. A limitation of these early data is that they only assess outcomes over three years. To estimate the full effect of these therapies, we will extrapolate the Kaplan-Meier curves for additional analyses. Clinical outcomes of second-line CAR-T are promising, but prices would need to be considerably lower to enable equitable access and affordability.[Table: see text]
Pan-immune-inflammation value as a predictive biomarker for survival in advanced non-small cell lung cancer patients treated with immunotherapy.
Authors: Kenneth Sooi, Jia Li Low, Qing Hao Miow, Nesaretnam Barr Kumarakulasinghe, Raghav Sundar, Yiqing Huang
Journal: Journal of Clinical Oncology (2022)

e21095 Background: It is well known that chronic inflammation can enable immune escape by suppressing immune surveillance. This promotes cancer growth and development, which forms the basis of immune checkpoint inhibitors use. Pan-Immune-Inflammation Value (PIV), a type of immune-inflammatory biomarker, has shown predictive value in various cancer patient populations (colorectal, melanoma, breast, oesophagus, ALK-positive lung cancer) and patients with ANCA-associated vasculitis. We aimed to evaluate the role of PIV as a predictive biomarker in advanced non-small cell lung cancer (NSCLC), whereby immune checkpoint inhibitor therapy is frequently used. Methods: We conducted a retrospective review of advanced NSCLC patients who received immunotherapy in the National University Hospital, Singapore between January 2015 and January 2022. PIV was calculated as: (neutrophil count × platelet count × monocyte count)/lymphocyte count, with the median value used to distinguish between high and low PIV. Kaplan–Meier method and Cox proportional hazards regression models were used for survival analyses. Results: 203 patients were included in the study. The median age was 63, 70% were males, 76% were Chinese, 83% had ECOG Performance Status ≤1 and 70% had adenocarcinoma histology. The immunotherapy agents used were Pembrolizumab (82%), Nivolumab (13%) and Atezolizumab (5%). Chemotherapy was given in conjunction with immunotherapy in 37% of the population. The median PIV value derived was 790 and patients with a low baseline PIV experienced better progression-free survival (PFS) and overall survival (OS). The median PFS was 249 days in PIV-low vs 145 days in PIV-high cohorts (hazard ratio for progression or death from any cause [HR] 0.58, 95% Confidence Interval [CI] 0.40-0.86, p &lt; 0.01) and the median OS was 794 days in PIV-low vs 420 days in PIV-high cohorts (HR 0.69, 95% CI 0.49-0.96, p = 0.03). Patients who had higher PIV, ECOG performance status ≥2, liver metastases, immunotherapy exposure in 2 nd line or later, use of immunotherapy alone without chemotherapy had worse OS in univariate analysis, but only PIV (HR = 1.61, 95% CI 1.08-2.40, p &lt; 0.02) was an independent prognostic factor in multivariate analysis. Amongst the patients with known PD-L1 status (n = 158), univariate analysis showed that PD-L1 ≥1 and PD-L1 ≥50 were not prognostic for OS whereas PIV remained an independent prognostic factor in both univariate and multivariate analyses. Conclusions: PIV appears to be a strong predictor of survival outcomes for patients with advanced NSCLC receiving immunotherapy as part of their cancer treatment. Prospective clinical trials are required to validate the predictive value of PIV in NSCLC patients receiving immunotherapy, as well as evaluating PIV’s performance against PD-L1.
Cost-effectiveness of adjuvant chemotherapy for patients with high-risk stage II and stage III colon cancer in South Africa.
Authors: Yoanna S Pumpalova, Alexandra M. Rogers, Sarah Xinhui Tan, Candice-Lee Herbst, Paul Ruff, Alfred I. Neugut, Chin Hur
Journal: Journal of Clinical Oncology (2022)

6599 Background: Colon cancer (CC) incidence is rising globally, and case fatality rates are greatest in low-income settings, such as South Africa (SA). Adjuvant chemotherapy is standard of care for high-risk stage II and stage III CC in the US. We evaluated the cost-effectiveness of adjuvant chemotherapy for CC in SA public hospitals. Methods: We developed a decision-analytic Markov model comparing lifetime costs and outcomes for 60-year-old high-risk stage II and stage III CC patients treated in a SA public hospital with no adjuvant chemotherapy, versus: capecitabine and oxaliplatin (CAPOX) for 3 or 6 months or capecitabine for 6 months. High-risk stage II was defined as ≥1 of: T4 disease; poorly differentiated tumor; lymphovascular/perineural invasion; &lt;12 lymph nodes dissected, bowel obstruction/perforation. Transition probabilities were derived from clinical trials estimating toxicity, disease recurrence, and survival. Costs from a SA societal perspective and utility estimates were obtained from literature and local expert opinion. The primary outcome was the incremental cost-effectiveness ratio (ICER) in international dollars (I$) per disability-adjusted life year (DALY) averted, with a willingness-to-pay (WTP) threshold equal to 2021 GDP/capita of SA (I$13,764). Results: CAPOX for 3 months was the cost-effective strategy for stage III CC at a lifetime cost of I$5,284 and 5.55 DALYs averted, compared to no adjuvant treatment. All other strategies were absolutely dominated. For high-risk stage II CC, CAPOX for 3 months was the cost-effective strategy (ICER = I$711/DALY averted). No adjuvant chemotherapy was on the efficiency frontier, with a lower lifetime cost, but no DALYs averted. The results of one-way deterministic sensitivity analyses showed that the model is most sensitive to CC recurrence rate. In a probabilistic sensitivity analysis, CAPOX for 3 months was optimal in 88% of iterations for high-risk stage II CC and 79% of iterations for stage III CC. Conclusions: CAPOX for 3 months is the cost-effective adjuvant treatment for high-risk stage II and stage III CC in SA public hospitals. This strategy offers the highest quality of life benefit for the lowest cost and is well within the WTP threshold for SA. The optimal strategy in other settings will vary according to local WTP thresholds. Base case estimates of cost-effectiveness, in order of cost. [Table: see text]
Clinical and biologic predictors of response to MIBG therapy: A report from the new approaches to neuroblastoma therapy (NANT) consortium.
Authors: Kieuhoa Tran Vo, Katherine K. Matthay, Susan G. Groshen, Yueh-Yun Chi, Meaghan Granger, Julie R. Park, Araz Marachelian, Steven G. DuBois
Journal: Journal of Clinical Oncology (2022)

e22003 Background: 131 I-metaiodobenzylguanidine (MIBG) remains one of the most active agents for neuroblastoma. The clinical and biologic predictors of response to MIBG therapy have not been systematically characterized in a recent era trial. Methods: Patients 1-30 years were enrolled on the randomized phase 2 trial of MIBG vs. MIBG/vincristine/irinotecan vs. MIBG/vorinostat for relapsed/refractory neuroblastoma (NANT2011-01, NCT02035137) between 2014-2019. Data were compared between those who had an objective response (partial response or better using NANT response criteria) to MIBG after the first cycle and those who did not according to clinical features (age at study enrollment; sex; response to prior therapy; prior receipt of MIBG therapy; bone marrow involvement at study enrollment; and measurable disease status at study enrollment) and MYCN status. Univariate analyses were performed using odds ratio and Fisher exact tests. Multivariate logistic regression analysis was used to identify predictors of response to MIBG therapy while controlling for key confounders. Results: 105 response-evaluable patients were included in the analytic cohort. Across the 3 study arms, 20% (21/105) had an objective response to the treatment. Only measurable disease status was statistically significantly associated with response to therapy, with higher rates of response among patients without measurable disease at study enrollment (30% vs. 13%, p = 0.049). Response to prior therapy, sex, MYCN status, and measurable disease status showed univariate odds ratios of 2 or greater (Table). Only measurable disease status remained statistically significant in the multivariate analysis (p = 0.043, Table). Conclusions: Patients without measurable disease have a higher rate of objective responses to MIBG therapy. Understanding these differences based upon predictors of response may help to inform stratification methods for future MIBG clinical trials.[Table: see text]
Molecular features differences between patients with BRAF mutant melanoma and thyroid cancer.
Authors: Yingying Huang, Yun-Bo Zhao, Ke Ye, Liang Xiao, Guo Long, Tongdi Fang, Mingming Yuan, Xuefeng Xia, Ledu Zhou
Journal: Journal of Clinical Oncology (2022)

e15128 Background: The efficacy of BRAF inhibitors varies extremely among patients with different cancers, such as malignant melanoma (MM) and differentiated thyroid carcinoma (TC) (constituting &gt; 95% of thyroid cancer). This study aims to investigate molecular biomarkers that may explain the efficacy difference of BRAF inhibitors in patients with MM and TC. Methods: Tumor tissue and paired peripheral blood samples from patients with MM and TC were sent for matched tumor-normal next-generation sequencing of 1021 cancer-related genes. MM and TC patients harboring known BRAF activating mutations were retrospectively recruited in this study. Concomitant mutations, tumor mutation burden (TMB) and other mutational features were compared between these two populations. Results: A total of 69 patients with MM and 315 patients with TC were included. The total and median number of mutations in these two groups were 503/6 and 605/1, respectively. Correspondingly, TMB was higher in MM compared with TC (median: 2.88 muts/Mb vs. 0.69 muts/Mb, p = 0.0002). Compared with TC, more copy number variants (CNV) (total number: 142 vs 5, p &lt; 0.001) and less single nucleotide variants (total number: 353 vs 569, p &lt; 0.001) were identified in MM. Most BRAF mutations in MM were located on V600, and other mutations including D594A/G/N, K483E/Q and K601E were identified. In TC, nearly all mutations were BRAF V600E. Excluding CNV and structural variants, the mutation frequency of 28 genes in MM was higher than TC. Pathway enrichment analysis suggested that 9 out of 28 genes (APC, ARID1B, ARID2, CDKN2A, CTNNB1, EGFR, PTEN, TERT, TP53) were significantly enriched on the hepatocellular carcinoma signaling. TERT, CDKN2A and PTEN were frequently mutated in MM, which may contribute to the efficacy difference of BRAF inhibitors in patients with MM and TC. Conclusions: This study found specific molecular features may explaining the efficacy difference of BRAF inhibitors in MM and TC, which requires further validation in patients treated with BRAF inhibitors.
Understanding barriers and facilitators to clinical trial participation among Black patients with multiple myeloma.
Authors: Claire Saxton, Asia Cutforth, Maria Belen Gonzalo, Helen Nichosl, Kirstin Fearnley
Journal: Journal of Clinical Oncology (2022)

12137 Background: Currently, Black patients make up 20% of people living with multiple myeloma, yet they represent only 6% of participants in clinical trials. 1 The underrepresentation of Black patients in clinical trials can contribute to outcome disparities thereby negatively impacting health equity in cancer treatment and outcomes. 2 This project examined attitudes towards clinical trials among Black multiple myeloma patients and caregivers. Findings will inform the development of programs aimed at increasing clinical trial participation in this population. Methods: In 2021, the Cancer Support Community conducted an online survey to gain insights on barriers, facilitators, and perceptions of clinical trials among Black multiple myeloma patients and caregivers/care partners. Survey questions were informed by insights from prior focus groups. 94 patients and 101 caregivers were surveyed. Results: Most participants were male (62%) and African American (90%). 5% identified as African Caribbean and 5% as Black and Hispanic. The average age was 46 years. Just over half (51%) currently or previously participated in clinical trials. Of those who chose not to participate in a trial, the most common reasons were fear of side effects (46%) and fear of receiving a placebo (38%). Another barrier to participation reported was discomfort with being randomly assigned to a treatment (56%). Participants reported a significant level of distrust in medical research and doctors, saying that it was “very or somewhat likely” that doctors provide treatment as part of an experiment without patient consent (41%) and that they might be used as a “guinea pig” (25%). Of note, 57% of respondents said COVID had changed their attitude towards participating in clinical trials. 14 of 16 factors mentioned in our focus groups were affirmed by more than half of respondents as facilitating participation in a clinical trial. The top factors were: Understanding potential side effects (66%) My health care team speaks to me about trials (65%) Compensation offered for transportation, childcare, or time off work (62%) My family/community support my decision (61%). Conclusions: These findings are consistent with previous research which found that cancer patients reported the biggest attitudinal barriers to clinical trial participation were fear of side effects, distrust in medical research, and random assignment to clinical trial groups. 3 Our study highlights that Blacks and African Americans living with multiple myeloma value multifactorial efforts to increase clinical trial participation: logistical and financial interventions, patient/provider communication, and culturally sensitive support and education programs. These programs can also work to improve health equity by reducing barriers to overall care and encouraging Blacks and African Americans living with multiple myeloma to be active members of their health care team.
Real-world frequency of non-small cell lung cancer with ERBB2 exon 20 insertion (Exon20ins) mutations by site of insertion.
Authors: Li Yang, Tanxiao Huang, Yuan Qu, Qichen Wang, Jiaman Teng, Bo Yang, Shifu Chen, Feng-Ming Spring Kong
Journal: Journal of Clinical Oncology (2022)

e15026 Background: ERBB2 Exon20ins mutations are in-frame insertions or duplications clustered around 2 key regions of Exon 20: the α-C helix (amino acid [AA] 770-774), the loop following the α-C helix (amino acid [AA] 775-783). The site of insertion can influence the outcome to selective EGFR/ERBB2 tyrosine kinase inhibitor therapy; ERBB2 exon 20 insertion mutation remains an unmet clinical need. The next-generation sequencing technology is a powerful tool to investigate the detailed ERBB2 mutations sites. Methods: We used real-world HaploX genomic data from patients (pts) with non-small cell lung cancer (NSCLC) to determine the frequency of ERBB2 Exon20ins mutations by site of insertion.The tumor tissue or serial blood sample was collected for each individual and the next-generation sequencing was performed using customized target captured HapOncoCDx panels. Results: From HaploX genomic data, 284/18205 pts (1.56%) with NSCLC had ERBB2 Exon20ins mutations: 72.2% were located in the helix, 27.8% in the loop (Table). The top 3 most frequent sites of insertion were Y772_A775dup (71.5%), G776delinsVC (11.3%), and G778_P780dup (6.0%). Conclusions: This real-world databases identified the helix as the most frequent insertion region of Exon 20 (∼72%). Exon20ins mutations were found less frequently in the loop (∼28%).[Table: see text]